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Regulatory
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Take your (Niemann-) Pick: Intrabio’s Aqneursa wins FDA nod

Sep. 25, 2024
By Randy Osborne
With two drugs cleared by the U.S. FDA for Niemann-Pick disease type C (NPC) in less than seven days, Wall Street was pondering the differences between the compounds, given what’s known so far about each. Most recently, the FDA approved Intrabio Inc.’s Aqneursa (levacetylleucine) on its PDUFA date for the treatment of neurological manifestations of NPC in adults and pediatric patients weighing at least 15 kg, making Aqneursa the only approved stand-alone therapy indicated for NPC. On Sept. 20, Zevra Therapeutics Inc. won FDA clearance for Miplyffa (arimoclomol) as the first treatment for NPC.
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Immuno-oncology art concept
Immuno-oncology

KSQ Therapeutics’ TIL therapy cleared to enter clinic for solid tumors

Sep. 25, 2024
The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.
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Endocrine/metabolic

Arrowhead seeks clearance to advance ARO-INHBE into clinic for obesity

Sep. 25, 2024
Arrowhead Pharmaceuticals Inc. has filed for regulatory clearance to initiate a phase I/IIa trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed for obesity.
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ODAC to explore PD-L1 levels’ limit case in PD-1 therapy

Sep. 24, 2024
By Randy Osborne
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
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Ozempic, Wegovy pricing confab HELP’s next step

Sep. 24, 2024
By Mari Serebrov
While in the hot seat at a Sept. 24 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing, Novo Nordisk A/S President and CEO Lars Fruergaard Jørgensen said he would sit down with Sen. Bernie Sanders (I-Vt.) and the three largest pharmacy benefit managers to discuss lowering the list prices for the company’s popular diabetes and weight-loss drugs, Ozempic and Wegovy.
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Leung Chun-ying, vice chairperson of the Chinese People’s Political Consultative Conference (CPPCCC) at Bio Hong Kong 2024

Hong Kong’s role grows as China moves to up, reform bio sector

Sep. 24, 2024
By Marian (YoonJee) Chu
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
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Astellas patent survives ‘natural law’ decision

Sep. 24, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
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United Kingdom flag, map

UK’s NICE sees digital health products as aids to therapist time

Sep. 24, 2024
By Mark McCarty
The U.K. National Institute for Health and Care Excellence reported that mental health professionals experienced a dramatic increase in referrals for anxiety and depression over the past decade but noted that digital therapies might help manage the caseload, representing a significant opportunity for developers of these products.
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U.S. FDA headquarters

Tarver says collaboration, health equity prime considerations

Sep. 24, 2024
By Mark McCarty
Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.
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Art concept for tumor
Immuno-oncology

FDA clears Chengdian (Suzhou) Biopharmaceutical’s IND for CD-001

Sep. 24, 2024
Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.
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